DEVICE: PENTAX (04961333228058)
Device Identifier (DI) Information
PENTAX
FCY-15RBS
In Commercial Distribution
HOYA CORPORATION
FCY-15RBS
In Commercial Distribution
HOYA CORPORATION
Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35980 | Flexible fibreoptic cystoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during cystoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine/diagnose incontinence, the inability to pass urine (retention), recurrent urinary tract infections, and to remove tissue samples/stones/small tumours from the bladder. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FAJ | Cystoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K914008 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b820c04f-d771-49ea-be58-ed599e7d4eba
September 27, 2018
4
April 07, 2017
September 27, 2018
4
April 07, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined